Trial Outcomes & Findings for Study of Stapled Transanal Rectal Resection (STARR) Surgery in Refractory Constipation Associated With Obstructive Defecation Syndrome (ODS) (NCT NCT00256984)

Results Overview

The primary endpoint used to assess effectiveness of STARR for treatment of ODS was the percentage of change in total ODS symptom composite score (0=worst, 24=best) 1 year after completion of the procedure.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

75 participants

Primary outcome timeframe

one year from Baseline

Results posted on

2018-07-16

Participant Flow

Participant milestones

Participant milestones
Measure	Stapled Trans-Anal Rectal Resection (STARR) STARR procedure (an anterior and posterior, full-thickness stapling and resection of the rectal wall) to correct Obstructive Defecation Syndrome symptoms utilizing the TransStar Circular Stapler
Overall Study STARTED	75
Overall Study COMPLETED	59
Overall Study NOT COMPLETED	16

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study of Stapled Transanal Rectal Resection (STARR) Surgery in Refractory Constipation Associated With Obstructive Defecation Syndrome (ODS)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Stapled Trans-Anal Rectal Resection (STARR) n=75 Participants STARR procedure (an anterior and posterior, full-thickness stapling and resection of the rectal wall) to correct Obstructive Defecation Syndrome symptoms utilizing the TransStar Circular Stapler
Age, Continuous	48 years n=5 Participants
Sex: Female, Male Female	75 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
ODS composite score	6.19 units on a scale STANDARD_DEVIATION 3.13 • n=5 Participants
number of subjects in each age range having STARR procedure <=29 years	4 participants n=5 Participants
number of subjects in each age range having STARR procedure Between 30 and 39 years	9 participants n=5 Participants
number of subjects in each age range having STARR procedure Between 40 and 49 years	26 participants n=5 Participants
number of subjects in each age range having STARR procedure Between 50 and 59 years	18 participants n=5 Participants
number of subjects in each age range having STARR procedure Between 60 and 69 years	11 participants n=5 Participants
number of subjects in each age range having STARR procedure >=70 years	7 participants n=5 Participants

PRIMARY outcome

Timeframe: one year from Baseline

Population: Per protocol

The primary endpoint used to assess effectiveness of STARR for treatment of ODS was the percentage of change in total ODS symptom composite score (0=worst, 24=best) 1 year after completion of the procedure.

Outcome measures

Outcome measures
Measure	Stapled Trans-Anal Rectal Resection (STARR) n=59 Participants STARR procedure (an anterior and posterior, full-thickness stapling and resection of the rectal wall) to correct Obstructive Defecation Syndrome symptoms utilizing the TransStar Circular Stapler
Percentage of Change (Reduction) in Total ODS Symptom Composite Score From Baseline to One Year Post Procedure	60.8 percentage of change Standard Deviation 35.46

SECONDARY outcome

Timeframe: Baseline, 1 month post procedure

Percentage of change in Obstructive Defecation Syndrome (ODS) symptom composite score from baseline at 1 month post procedure. This score is based on a series of questions designed to understand the extent ODS effects an individual's daily lifestyle (0 is worst score, 24 is best score). Sizing consistent with primary outcome; analysis was per-protocol.

Outcome measures

Outcome measures
Measure	Stapled Trans-Anal Rectal Resection (STARR) n=59 Participants STARR procedure (an anterior and posterior, full-thickness stapling and resection of the rectal wall) to correct Obstructive Defecation Syndrome symptoms utilizing the TransStar Circular Stapler
Percentage of Change in ODS Symptom Composite Score From Baseline at 1 Month Post Procedure	-50.7 percentage of change Standard Deviation 34.4

SECONDARY outcome

Timeframe: Baseline, 6 months

Assessed as patient-reported assessment of symptom severity and frequency (PAC-SYM)associated with constipation. Patient response options are absent, mild, moderate, severe, and very severe.12 questions relate to severity, 8 questions relate to frequency of symptoms. The lower the score, the less severe the symptoms. Sizing consistent with primary outcome; analysis was per-protocol.

Outcome measures

Outcome measures
Measure	Stapled Trans-Anal Rectal Resection (STARR) n=59 Participants STARR procedure (an anterior and posterior, full-thickness stapling and resection of the rectal wall) to correct Obstructive Defecation Syndrome symptoms utilizing the TransStar Circular Stapler
Maximum Change in Subject-reported Assessment of Symptom Severity and Frequency (PAC SYM).	1.43 units on a scale Standard Deviation 0.72

SECONDARY outcome

Timeframe: Baseline, 6 months post procedure

The primary endpoint used to assess effectiveness of STARR for treatment of ODS was the percentage of change in total ODS symptom composite score (0=worst, 24=best) 1 year after completion of the procedure.

Outcome measures

Outcome measures
Measure	Stapled Trans-Anal Rectal Resection (STARR) n=59 Participants STARR procedure (an anterior and posterior, full-thickness stapling and resection of the rectal wall) to correct Obstructive Defecation Syndrome symptoms utilizing the TransStar Circular Stapler
Percentage of Change in ODS Symptom Composite Score From Baseline at 6 Months (0 is Worst Score, 24 is Best Score)	-57.0 percentage of change Standard Deviation 34.4

SECONDARY outcome

Timeframe: Baseline, 12 months

Population: Sizing consistent with primary outcome; analysis was Intent-to-Treat

PAC-QOL is Patient Assessment of Constipation, Quality of Life. The instrument consists of 28 questions on a 0-4 scale. A lower score indicates better quality of life. The score is a number without units.Change from baseline in patient assessment of constipation in quality of life as measured by the PAC QOL instrument score. The questions are designed to measure the impact constipation has had on daily life during the week prior to the subject visit. Sizing was consistent with the primary outcome; analysis was per-protocol

Outcome measures

Outcome measures
Measure	Stapled Trans-Anal Rectal Resection (STARR) n=59 Participants STARR procedure (an anterior and posterior, full-thickness stapling and resection of the rectal wall) to correct Obstructive Defecation Syndrome symptoms utilizing the TransStar Circular Stapler
PAC QOL Patient Assessment of Constipation (Overall)	0.95 units on a scale Standard Deviation 0.996

SECONDARY outcome

Timeframe: Baseline, 12 Months

The SF-12 is a validated 12 question quality-of-life questionnaire. The SF-12 extracts 12 items from the SF-36 questionnaire in two six-item subscales, PCS (physical functioning) and MCS (emotional functioning). The SF-12 scores can range from 10 (maximum impairment) to 70 (no impairment). For this study, the endpoint is the percentage of change from baseline over 12 months post procedure.

Outcome measures

Outcome measures
Measure	Stapled Trans-Anal Rectal Resection (STARR) n=59 Participants STARR procedure (an anterior and posterior, full-thickness stapling and resection of the rectal wall) to correct Obstructive Defecation Syndrome symptoms utilizing the TransStar Circular Stapler
SF-12 QOL Change From Baseline (Physical Component)at 12 Months	6.32 units on a scale Standard Deviation 9.106

SECONDARY outcome

Timeframe: Baseline, 12 months

SF 12 change from baseline, mental component. The SF-12 is a validated 12 question quality-of-life questionnaire. The SF-12 extracts 12 items from the SF-36 questionnaire in two six-item subscales, PCS (physical functioning) and MCS (emotional functioning). The SF-36 scores range from 0 (maximum impairment) to 100 (no impairment), the SF-12 scores range from 10 (maximum impairment) to 70 (no impairment). For this study, the endpoint is the percentage of change from baseline over 12 months post procedure.

Outcome measures

Outcome measures
Measure	Stapled Trans-Anal Rectal Resection (STARR) n=59 Participants STARR procedure (an anterior and posterior, full-thickness stapling and resection of the rectal wall) to correct Obstructive Defecation Syndrome symptoms utilizing the TransStar Circular Stapler
SF-12 QOL Change (Mental Component) at 12 Months From Baseline	4.83 units on a scale Standard Deviation 11.67

Adverse Events

Stapled Trans-Anal Rectal Resection (STARR)

Serious events: 14 serious events

Other events: 33 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Stapled Trans-Anal Rectal Resection (STARR) n=75 participants at risk STARR procedure (an anterior and posterior, full-thickness stapling and resection of the rectal wall) to correct Obstructive Defecation Syndrome symptoms utilizing the TransStar Circular Stapler
Investigations Blood count abnormal	1.3% 1/75 • 1 year
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	1.3% 1/75 • 1 year
Surgical and medical procedures Colostomy	1.3% 1/75 • 1 year
Metabolism and nutrition disorders Diabetic ketoacidosis	1.3% 1/75 • 1 year
Infections and infestations Gastroenteritis	1.3% 1/75 • 1 year
Injury, poisoning and procedural complications Gastrointestinal injury	1.3% 1/75 • 1 year
Infections and infestations Haematoma infection	1.3% 1/75 • 1 year
Gastrointestinal disorders Intestinal hypomotility	1.3% 1/75 • 1 year
Injury, poisoning and procedural complications Postprocedural haemorrhage	2.7% 2/75 • 1 year
Gastrointestinal disorders Rectal haemorrhage	1.3% 1/75 • 1 year
Gastrointestinal disorders Rectal perforation	1.3% 1/75 • 1 year
Injury, poisoning and procedural complications Suture related complication	1.3% 1/75 • 1 year
Gastrointestinal disorders Umbilical hernia	1.3% 1/75 • 1 year
Renal and urinary disorders Urinary retention	2.7% 2/75 • 1 year

Other adverse events

Other adverse events
Measure	Stapled Trans-Anal Rectal Resection (STARR) n=75 participants at risk STARR procedure (an anterior and posterior, full-thickness stapling and resection of the rectal wall) to correct Obstructive Defecation Syndrome symptoms utilizing the TransStar Circular Stapler
Nervous system disorders Dizziness	8.0% 6/75 • 1 year
Psychiatric disorders Insomnia	9.3% 7/75 • 1 year
Skin and subcutaneous tissue disorders Pruritus	8.0% 6/75 • 1 year
Renal and urinary disorders urinary retention	18.7% 14/75 • 1 year

Additional Information

Susan Knippenberg, Clinical Scientist

Ethicon Endo-Surgery

Phone: 513 337-3452

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60